Promoting Well-being and Health in Heart Failure

A Novel Behavioral Intervention to Promote Adherence in Heart Failure

The focus of this study is to test the efficacy of a 12-week, phone-delivered Positive Psychology-Motivational Interviewing (PP-MI) intervention, with additional twice weekly PP and health behavior text messages for a total of 24 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 12 weeks), compared to an attention-matched MI-based educational condition, in a randomized trial (NIH Stage II) of 280 patients with New York Heart Association class I-III Heart Failure (HF).

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Heart Failure NYHA Class II; Heart Failure NYHA Class III; Heart Failure NYHA Class I
• Intervention / Treatment: Behavioral: PP-MI Intervention; Behavioral: MI-alone Intervention

Detailed Description

The investigators are proposing a study that will focus on testing the efficacy of a Positive Psychology-Motivational Interviewing (PP-MI) intervention, with additional twice weekly PP and health behavior text messages for a total of 24 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 12 weeks) in patients with New York Heart Association class I-III HF. The investigators will enroll 280 HF patients, who will take part in a 12-week (with 24 weeks of supplemental text messages) health behavior intervention.

In this project, the investigators hope to do the following:

1. Examine the efficacy of a 12-week, phone-delivered PP-MI intervention for individuals with heart failure (HF) on health behavior adherence at 12 weeks (primary time point), 24 weeks, and 48 weeks.
2. Assess the intervention's impact on psychological outcomes, health-related quality of life (HRQoL), HF-specific quality of life, HF symptoms, and function.
3. Explore the intervention's impact on markers of cardiovascular health (e.g., blood pressure), as well as major adverse cardiac events, HF hospitalizations, and mortality.

Participants will undergo two visits (in-person or virtual) during which they will meet with study staff. During the first visit, participants will provide informed consent, answer questionnaires related to psychological and physical health and functioning, have their blood pressure and weight measured, and be asked to monitor their physical activity (using an accelerometer) for one week and medication adherence (using an electronic pill bottle) for two weeks. Participants will be given a urine collection container and asked to provide a urine sample within 4 hours of their first void and before eating breakfast on the day of Visit 2. At the second visit, the urine sample will be collected, and upon confirmation of adequate physical activity and medication adherence data, participants will be randomized to receive the PP-MI intervention or the MI-alone intervention.

Following randomization, all participants will be provided a treatment manual corresponding with their treatment condition, a Fitbit activity tracker, and other treatment materials. The appropriate intervention will be introduced, and the first exercise will be assigned.

Following the second visit, participants in both treatment conditions will complete twelve weekly phone sessions with a study trainer. The phone sessions primarily will include a review of the prior week's session content and a discussion of the rationale and assignment of the next week's exercise/assignment.

Participants in both treatment conditions will receive twice weekly text messages throughout the intervention (Weeks 1-12) and initial follow-up period (Weeks 13-24). During the intervention, these messages will provide information about the PP activity (PP-MI group) and health behavior goal (both groups) discussed that week. During Weeks 13-24, participants in the PP-MI condition will engage with twice weekly, automated, interactive text messages related to PP and health behavior goals. Individuals in the MI-alone group will receive identical messages related to setting health behavior goals as the PP-MI participants and will additionally receive a fixed test message providing education about health behavior adherence.

At Weeks 12, 24, and 48, participants will complete follow-up visits. One week prior to these visits, participants will be mailed an accelerometer and will wear it until their study visit. They will also be sent a container for urine collection, which they will bring to their follow-up visit. During these study visits, participants will be asked to answer questionnaires related to psychological and physical health and functioning, have their blood pressure, weight, and waist circumference measured, will perform a 6 minute walk test, and be asked about cardiovascular outcomes, including hospitalizations, cardiovascular procedures, and cardiac-specific hospitalizations.

Finally, participants will complete phone sessions every 6 months until study end to inquire about hospitalizations and adverse cardiac events.

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christohper M Celano, MD; Phone Number: 617-726-6485; Email: ccelano@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Christopher Celano, MD; Phone Number: 617-726-6485; Email: ccelano@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients with NYHA class I, II, or III HF.
• Suboptimal adherence to health behaviors. This will be defined as a total score of ≤15 on three Medical Outcomes Study Specific Adherence Scale (MOS) items regarding diet/exercise/medications.

Exclusion Criteria:

• Cognitive deficits impeding a participant's ability to provide informed consent or participate, assessed via a 6-item cognitive test.
• Medical conditions likely to lead to death within 6 months.
• Inability to participate in physical activity due to another medical condition (e.g., arthritis).
• Inability to read, write, or speak in English.
• Current participation in another intervention or program that has been designed to promote well-being or health behavior adherence.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PP-MI Intervention; Participants will receive a 12-week, Positive Psychology-Motivational Interviewing (PP-MI) intervention. Each week, participants will complete a PP activity and work towards one or more health behavior goals, then complete a phone session with a study trainer. Each weekly session will include PP and goal setting portions. In the PP portion, a study trainer will (a) review the week's PP exercise, (b) discuss the rationale of the next week's PP exercise through a guided review of the PP-MI manual, and (c) assign the next week's PP exercise. Additionally for the goal-setting portion, the trainer will (a) review their goals and health behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week. Finally, participants will receive supplemental text messages throughout the 12 weeks of the intervention and during the initial follow-up period (Week 13-24).	Behavioral: PP-MI Intervention; The 12-week PP-MI intervention focuses on enhancing well-being (through PP) and promoting adherence to physical activity, diet, and medications (through MI). Each week, participants will complete a PP activity and work towards one or more health behavior goals, then complete a phone session with a study trainer. The PP portion of the program will focus on the cultivation of well-being through the performance of easy-to complete activities (e.g., using a strength in a new way) and review of the positive feelings they generate. The MI portion of the program will focus on assisting participants to monitor health behavior adherence, resolve ambivalence to behavior change, set realistic health behavior goals, problem-solve barriers, and identify resources to complete behavior change. Finally, participants will receive twice weekly text messages (for 24 weeks) to encourage completion of PP activities and engagement in health behaviors.
Active Comparator: MI-alone Intervention; This condition will mirror the MI component of the PP-MI intervention. During the first three sessions, participants will learn about the causes and types of HF, risk factors for cardiovascular disease, and methods for monitoring risk factors and symptoms. Then participants will complete nine sessions related to physical activity, a low sodium diet, and medication adherence. Weekly tasks (e.g., brainstorming barriers) will be assigned, completed between calls, and reviewed at the following call. Finally, participants will receive supplemental text messages throughout the 12 weeks of the intervention and during the initial follow-up period (Week 13-24).	Behavioral: MI-alone Intervention; The time- and attention-matched MI-alone intervention focuses on providing education about heart failure (HF) and promoting adherence to physical activity, diet, and medications. Each week, participants will independently complete an activity related to HF education or adherence to a health behavior, then complete a phone session with a study trainer. HF educational topics will include the causes and types of HF, risk factors for cardiovascular disease, methods for monitoring risk factors and symptoms, and the importance of adherence to physical activity, diet, and medications. For each health behavior, study trainers will assist participants to monitor adherence, identify realistic behavior goals, problem-solve barriers, and identify resources to complete behavior change. Finally, participants will receive twice weekly text messages (for 24 weeks) that provide education and encourage engagement in health behaviors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health behavior adherence	Composite score of overall activity (measured by accelerometer in steps/day), sodium excretion (urine sodium in mEq/day), and medication adherence (Medication Event Monitoring System [MEMS] electronic pill bottle). This composite score will be created by calculating z scores for each individual outcome measure and then averaging them for each participant at each time point.	Baseline, 12 Weeks, 24 Weeks, 48 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity (in steps/day)	Physical activity (steps) will be measured via an accelerometer. We will use established accelerometer protocols to measure the mean number of steps taken per day at each time point.	Measured for 7 days at baseline, 12 weeks, 24 weeks, and 48 weeks
Objective medication adherence (Medication Event Monitoring System [MEMS] pill bottles)	Medication adherence will be measured using MEMS electronic pill bottles. Participants will receive a MEMS pill bottle at the initial study visit and will be asked to put one cardiac medication (loop diuretic, ACE inhibitor, beta blocker, or aspirin, in that order) in the bottle and then use it throughout the study period (48 weeks). Adherence will be measured by the percentage of appropriate bottle openings over a 2-week period at baseline and the follow-up time points.	Measured for 14 days at baseline, 12 weeks, 24 weeks, and 48 weeks
Sodium Excretion (mEq/day)	Objective sodium intake will be assessed through the measurement of urinary sodium excretion. Participants will provide a sample of their second voiding of the day, and from this sample, urine sodium and urine creatinine will be measured.	Baseline, 12 weeks, 24 weeks, 48 weeks
Positive Affect (Positive and Negative Affect Schedule [PANAS] positive affect items)	Positive affect will be measured using the 10 positive affect items from the PANAS, a well-validated scale used in numerous other behavioral intervention trials.	Baseline, 12 weeks, 24 weeks, 48 weeks
Physical Function (PROMIS 20-item Physical Function Short Form [PF-20])	The PROMIS 20-item short form (PF-20) will be used to assess physical function.	Baseline, 12 weeks, 24 weeks, 48 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moderate to Vigorous Physical Activity (MVPA)	MVPA (reported in mean minutes of MVPA/day) will be measured via an accelerometer and recorded in mean minutes/day.	Measured for 7 days at baseline, 12 weeks, 24 weeks, and 48 weeks
Sedentary Time (mean minutes/day)	Sedentary time (mean minutes/day) will be measured via Actigraph accelerometer.	Measured for 7 days at baseline, 12 weeks, 24 weeks, and 48 weeks
Self-reported sodium intake (Scored Sodium Questionnaire [SSQ])	The Scored Sodium Questionnaire (SSQ) measures the frequency with which individuals have consumed sodium-containing foods in the past month.	Baseline, 12 weeks, 24 weeks, 48 weeks
Self-report medication adherence (tool from the NHLBI Heart and Soul Study)	Medication adherence will be measured with the self-report medication adherence tool from the NHLBI Heart and Soul Study.	Measured for 14 days at baseline, 12 weeks, 24 weeks, and 48 weeks
Optimism (Life Orientation Test - Revised [LOT-R])	Optimism will be measured using the LOT-R, a frequently used 6-item instrument that assesses dispositional optimism.	Baseline, 12 weeks, 24 weeks, 48 weeks
Self-efficacy (General Self-Efficacy Scale [GSE])	Self-efficacy will be measured using the General Self Efficacy scale (GSE), a validated measure of self-efficacy, given its links to improved adherence.	Baseline, 12 weeks, 24 weeks, 48 weeks
Depressive symptoms (Hospital Anxiety and Depression Scale - depression subscale [HADS-D])	Depressive symptoms will be measured using the 7-item depression subscale of the HADS.	Baseline, 12 weeks, 24 weeks, 48 weeks
Anxiety (Hospital Anxiety and Depression Scale - anxiety subscale [HADS-A])	Anxiety will be measured using the 7-item anxiety subscale of the HADS.	Baseline, 12 weeks, 24 weeks, 48 weeks
Locus of control (Form C of the Multidimensional Health Locus of Control scale [MHLC Form C])	Locus of control will be measured using the 18-item MHLOC.	Baseline, 12 weeks, 24 weeks, 48 weeks
Health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12])	The SF-12 will be used to assess health-related quality of life. The SF-12 produces both mental and physical component scores, both of which will be assessed this trial.	Baseline, 12 weeks, 24 weeks, 48 weeks
HF-related quality of life (Kansas City Cardiomyopathy Questionnaire [KCCQ] quality of life score)	HF-related quality of life will be assessed using the quality of life score from the KCCQ.	Baseline, 12 weeks, 24 weeks, 48 weeks
HF symptoms (Kansas City Cardiomyopathy Questionnaire [KCCQ] total symptom score)	HF symptoms will be measured using the KCCQ total symptom score.	Baseline, 12 weeks, 24 weeks, 48 weeks
Systolic and diastolic blood pressure	Blood pressure (diastolic and systolic) will be measured by trained nurses using a standardized protocol.	Baseline, 12 weeks, 24 weeks, 48 weeks
Body mass index	Height and weight (for calculation of body mass index) will be measured by trained nurses.	Baseline, 12 weeks, 24 weeks, 48 weeks
Waist circumference	Waist circumference will be measured by trained nurses and/or dieticians.	Baseline, 12 weeks, 24 weeks, 48 weeks
LDL and HDL cholesterol	Fasting lipids (including LDL and HDL cholesterol) will be measured via blood samples.	Baseline, 12 weeks, 24 weeks, 48 weeks
Triglycerides	Fasting lipids (including triglycerides) will be measured via blood samples.	Baseline, 12 weeks, 24 weeks, 48 weeks
Fasting blood glucose	Fasting blood glucose levels will be measured via a blood sample.	Baseline, 12 weeks, 24 weeks, 48 weeks
6-minute walk test (in meters traveled)	A 6-minute walk test will be measured and monitored by trained nurses and/or dieticians to measure functional capacity.	Baseline, 12 weeks, 24 weeks, 48 weeks
Major Adverse Cardiac Events (MACE)	MACE will be defined as mortality or hospitalization for HF or an acute coronary event (percutaneous coronary intervention or acute coronary syndrome). Data regarding hospitalizations and mortality will be obtained using a three-pronged approach consisting of systematic queries of participants, electronic health record review, and review of records from the National Death Index.	Throughout study period (estimated mean duration 28 months)
All-cause Hospitalizations	We will record all-cause hospitalizations for all participants from enrollment to the end of the study data collection period, using systematic queries of participants and review of electronic health records from all Mass General Brigham-affiliated hospitals.	Throughout study period (estimated mean duration 28 months)
Heart Failure Hospitalizations	We will record HF hospitalizations for all participants from enrollment to the end of the study data collection period, using systematic queries of participants and review of electronic health records from all Mass General Brigham-affiliated hospitals.	Throughout study period (estimated mean duration 28 months)
Mortality	We will record vital status for participants from enrollment to the end of study data collection. Data regarding mortality will be obtained using electronic health record review and review of records from the National Death Index.	Throughout study period (estimated mean duration 28 months)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Christopher M Celano, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Physical Activity; Motivational Interviewing; Positive Psychology; Medication Adherence; Low-Sodium Diet
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2021P000882

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: To promote sharing of study data with other researchers, we also will create a deidentified study dataset. We will include both item-level and summary scores for each scale and will include data from the baseline, 12-week, 24-week, and 48-week time points.
• IPD Sharing Time Frame: This information will be shared prior to the end of the study funding period.
• IPD Sharing Access Criteria: Investigators who are interested in obtaining access to this information will be asked to submit a request to the principal investigator outlining the proposed use of the data and would need to agree to certain conditions (e.g., not attempting to identify individual participants, destroying data once the use of the data is complete) prior to obtaining access.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No